MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A34-34/C100-O20 V

Device Problem Stretched (1601)

Patient Problem Failure of Implant (1924)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported event of stent cage dilation.Event relatedness, procedure related harms and the final patient condition could not be determined with the medical available for review.No additional investigation of this reported event is planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

Event Description

At the completion of the clinical assessment on (b)(6) 2018, for a pervious report event (2031527-2018-00877), clinical was able to find substantial evidence to support the following additional findings of stent cage dilation of both the bifurcated stent graft (main body) and the suprarenal stent graft extension (cuff).This report is for the stent cage dilation of the cuff (suprarenal stent graft extension) only.

• Brand Name: AFX
• Type of Device: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 8263085
• MDR Text Key: 133694008
• Report Number: 2031527-2019-00048
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)150606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: A34-34/C100-O20 V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR